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RTOG 0825 Phase III GBM Salvage Treatment Summary Form (SF) Temozolomide and Radiation Therapy With or Without Bevacizumab in Treating Patients With Newly Diagnosed Glioblastoma Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=5AE2A23C-8AF1-6A8B-E044-0003BA3F9857

Link:

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=5AE2A23C-8AF1-6A8B-E044-0003BA3F9857

Keywords:

Brain Neoplasms

Clinical Trial

Treatment Form

Central Nervous System Neoplasms

Versions (4)

8/26/12 8/26/12 -
1/9/15 1/9/15 - Martin Dugas
1/9/15 1/9/15 - Martin Dugas
1/9/15 1/9/15 - Martin Dugas

Uploaded on:

January 9, 2015

DOI:

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License :

Creative Commons BY-NC 3.0 Legacy

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Brain and Central Nervous System Tumors NCT00884741 Treatment - RTOG 0825 Phase III GBM Salvage Treatment Summary Form (SF) - 2797440v1.0

English 1

English

Details

INSTRUCTIONS: Submit this form at the completion of each cycle of salvage treatment. Dates are to be recorded as mm-dd-yyyy unless otherwise specified

1 forms

StudyEvent: RTOG 0825 Phase III GBM Salvage Treatment Summary Form (SF)
1. INSTRUCTIONS: Submit this form at the completion of each cycle of salvage treatment. Dates are to be recorded as mm-dd-yyyy unless otherwise specified

Module 1

RTOG Study No.

Case #

Institution Name

Institution No.

Patient Initials

RTOG Patient ID

Amended Data (INSTRUCTIONS: Complete form on web to unblind the protocol treatment arm)

Yes

Assessment

Height (CM)

Weight (CM)

BSA (M2)

Karnofsky Performance Status (Use 9 if unknown)

Dead (0)

Moribund, Fatal Processes Progressing Rapidly (10)

Normal, No Complaints, No Evidence Of Disease (100)

Very Sick, Hospitalization Indicated. Death Not Imminent (20)

7 more items in the detailed view.

Neurologic function

Minor Neurologic Symptoms, Fully Active At Home/work Without Assistance (Minor neurologic symptoms, fully active at home/work without assistance)

Moderate Neurologic Symptoms, Fully Active At Home/work But Requires Assistance (Moderate neurologic symptoms, fully active at home/work but requires assistance)

Moderate Neurologic Symptoms, Less Than Fully Active At Home/work And Requires Assitance (Moderate neurologic symptoms, less than fully active at home/work and requires assistance)

No Neurologic Symptoms, Fully Active At Home/work Without Assistance (No neurologic symptoms, fully active at home/work without assistance)

Severe Neurologic Symptoms, Totally Inactive Requiring Complete Assistance At Home Or Institution, Unable To Work (Severe neurologic symptoms, totally inactive requiring complete assistance at home or institution, unable to work)

Unknown (Unknown)

Disease Progression

Salvage treatment being reported

Bevacizumab Alone (Bevacizumab alone)

Bevacizumab And Irinotecan (Bevacizumab and Irinotecan)

Bevacizumab And Tmz Salvage (Bevacizumab and TMZ salvage)

Is protocol chemotherapy continuing?

Yes

Unnamed 3

Agent Name

Agent Start Date (MM DD YYYY)

Agent End Date (MM DD YYYY)

Agent Total Dose (MG)

Total number of doses

Was dose reduced more than 20%

Yes

Reason for Treatment Modification

Adverse Event/side Effects/complications (Adverse event/side effects/complications)

Alternative Therapy (Alternative therapy)

Death On Study (Death on study)

Disease Progression, Relapse During Active Treatment (Disease progression, relapse during active treatment)

4 more items in the detailed view.

Reason Treatment Ended

Adverse Event/side Effects/complications (Adverse Event/Side Effects/Complications)

Alternative Therapy (Alternative therapy)

Death On Study (Death on study)

Disease Progression, Relapse During Active Treatment (Disease progression, relapse during active treatment)

5 more items in the detailed view.

Alternative therapy, specify

Other specify

Protocol Specific Adverse Event Evaluation

Were there any hemorrhage events during this report period

Yes

MedDRA Code

CTC Adverse Event Term

CTC AE Grade

CTCAE Begin Date (MM DD YYYY)

CTC AE Attribution Code

Definite (Definite)

Possible (Possible)

Probable (Probable)

Unlikely (Unlikely)

Unrelated (Unrelated)

CTC AE Attribution Code

Definite (Definite)

Possible (Possible)

Probable (Probable)

Unlikely (Unlikely)

Unrelated (Unrelated)

SAE report submitted

No (No)

Unknown (Unknown)

Yes (Yes)

SAE report submitted

No (No)

Unknown (Unknown)

Yes (Yes)

INR (International Normalized Ratio of prothrombin time Value)

INR LLN (Institution)

INR ULN (Institution)

PTT (sec) (Partial Thromboplastin Time Value)

PTT LLN (Institution)

seconds

PTT ULN (Institution)

seconds

PT (Prothrombin Time Value)

seconds

PT LLN (Institution)

seconds

PT ULN (Institution)

seconds

Platelets (PLT) (Platelets x 1000 cmm Value)

1000/uL

PLT LLN (Institution)

PLT ULN (Institution)

Date (MM DD YYYY)

Protocol Specific Adverse Event Evaluation

Were there any study-specific adverse events during this report period

Yes

CTC Adverse Event Term

CTC AE Grade

CTCAE Begin Date (MM DD YYYY)

CTC AE Attribution Code

Definite (Definite)

Possible (Possible)

Probable (Probable)

Unlikely (Unlikely)

Unrelated (Unrelated)

SAE report submitted

No (No)

Unknown (Unknown)

Yes (Yes)

Protocol Specific Adverse Event Evaluation

Any Treatment Related Adverse Events

No (No)

Unknown (Unknown)

Yes (Yes)

MedDRA Code

CTC Adverse Event Term

CTC AE Grade

CTCAE Begin Date (MM DD YYYY)

CTC AE Attribution Code

Definite (Definite)

Possible (Possible)

Probable (Probable)

Unlikely (Unlikely)

Unrelated (Unrelated)

SAE report submitted

No (No)

Unknown (Unknown)

Yes (Yes)

Footer Module

Comments

Signature of Person Completing This Form

Form Completion Date, Original

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Brain and Central Nervous System Tumors NCT00884741 Treatment - RTOG 0825 Phase III GBM Salvage Treatment Summary Form (SF) - 2797440v1.0

INSTRUCTIONS: Submit this form at the completion of each cycle of salvage treatment. Dates are to be recorded as mm-dd-yyyy unless otherwise specified

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